The Efficacy and Safety of Efsubaglutide Alfa in Overweight/Obesity(SPARKLE)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Yinnuo Pharmaceutical Technology Co., Ltd.

About this trial

This is a multicenter, double-blind, randomized, placebo-controlled phase Ⅱ study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YN-011 in subjects with overweight (27 kg/m2 ≤ BMI \< 30 kg/m2, with at least one comorbidity) or obesity (BMI ≥ 30 kg/m2, with or without comorbidities). The entire study period will consist of a 2-week screening period, a 22-week double-blind treatment period, and a 4-week off-treatment follow-up period

Eligibility criteria

Qualifiers

Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent form (ICF);

Male or female subjects, aged 18 to 75 years (both inclusive) at the time of signing the ICF;

Obese: BMI ≥ 30.0 kg/m2, with or without comorbidities; Or overweight: 27.0 kg/m2 ≤ BMI < 30.0 kg/m2, with at least one of the following weight-related comorbidities: pre-diabetes, hypertension, dyslipidemia, fatty liver, osteoarthritis, or obesity-induced obstructive sleep apnea syndrome (If the subject has only fatty liver as a comorbidity, imaging results within the 3 months prior to screening are required for fatty liver);

A self-reported change in body weight less than 5.0% controlled with diet and exercise within 3 months before screening;

Disqualifiers

Obesity caused by endocrine disease or monogenic mutation, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroidism-related obesity, Cushing's syndrome, insulinoma, acromegaly or hypogonadism;

Known or suspected allergy to the investigational medicinal product, its components or drugs of the same class;

Previously diagnosed diabetes mellitus (including type 1 diabetes mellitus, type 2 diabetes mellitus, diabetes mellitus due to pancreatic damage, or other types of diabetes mellitus [except gestational diabetes mellitus]);

History of severe gastrointestinal disease (e.g., active ulcers), or gastrointestinal surgery (except for appendectomy, cholecystectomy, or other gastrointestinal endoscopic surgeries deemed by the investigator to have no significant impact on gastrointestinal motility), or clinically significant gastric emptying abnormalities (e.g., pyloric obstruction, gastroparesis), or long-term use of drugs with direct effects on gastrointestinal motility within 6 months before screening, or those who were not suitable for participating in this study at the investigator's discretion;

Trial design

Treatments tested in this trial

  • Efsubaglutide Alfa 20 mg QW
  • Efsubaglutide Alfa 40 mg QW
  • Efsubaglutide Alfa 40 mg Q2W
  • Efsubaglutide Alfa 80 mg QW
  • Efsubaglutide Alfa 80 mg Q4W
  • Placebo

Treatment groups

200 Participants
are divided into 5 treatment groups